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Recruiting

NCT Number: NCT05750901

Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanctuary Plastic Surgery

Boca Raton, Florida, 33431, United States

Location status: Recruiting

Location contact

Jason Pozner, MD

CONTACT

561-367-9101

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects aged 18-85 years
  • Fitzpatrick skin type I-VI
  • Has visible skin laxity in the treatment region or has a scar
  • Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study (Applicable to female subjects only)
  • Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
  • Subject must be able to read, understand and sign Informed Consent Form in English
  • Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

Exclusion criteria

  • Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
  • Any type of prior cosmetic treatment to the target area at physicians' discretion
  • History of malignant tumors in the target area.
  • Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
  • Pregnant and/or breastfeeding (Applicable to females only)
  • Having an infection, dermatitis or a rash in the treatment area.
  • Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
  • Suffering from coagulation disorders or taking prescription anticoagulation medications.
  • History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  • History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
  • History of vitiligo, eczema, or psoriasis.
  • History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
  • History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
  • Current smoker or history of smoking within 6 months of study participation.
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Treatment and study plan

Fractional Ablative Laser

Device

Fractional ablative laser used for treatment for skin laxity and tightening

Primary outcomes

  1. Wrinkles

    Time frame: 1-6 months post final treatment

    Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Sciton Inc

CONTACT

[email protected]

6504939155

Sciton Inc.

CONTACT

[email protected]

6504939155

Sponsors and collaborators

Lead sponsor

Sciton

Industry

Registry information

Official study title

Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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